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EP3174548B1 - Peptides marins et nucleotides de poissons, compositions et leurs utilisations pour la reduction de la glycemie - Google Patents

Peptides marins et nucleotides de poissons, compositions et leurs utilisations pour la reduction de la glycemie Download PDF

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Publication number
EP3174548B1
EP3174548B1 EP15745185.7A EP15745185A EP3174548B1 EP 3174548 B1 EP3174548 B1 EP 3174548B1 EP 15745185 A EP15745185 A EP 15745185A EP 3174548 B1 EP3174548 B1 EP 3174548B1
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Prior art keywords
marine
subject
peptide
combination
marine peptide
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German (de)
English (en)
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EP3174548A1 (fr
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Oddvar BJORGE
Einar Lied
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Firmenich SA
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Firmenich SA
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/01—Hydrolysed proteins; Derivatives thereof
    • A61K38/012—Hydrolysed proteins; Derivatives thereof from animals
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L17/00—Food-from-the-sea products; Fish products; Fish meal; Fish-egg substitutes; Preparation or treatment thereof
    • A23L17/20—Fish extracts
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/13—Nucleic acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/18—Peptides; Protein hydrolysates
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/60—Fish, e.g. seahorses; Fish eggs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/612—Crustaceans, e.g. crabs, lobsters, shrimps, krill or crayfish; Barnacles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/02—Algae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/01—Hydrolysed proteins; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/01—Hydrolysed proteins; Derivatives thereof
    • A61K38/011—Hydrolysed proteins; Derivatives thereof from plants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • fish products and by-products are provided herein.
  • Postprandial blood glucose or glycaemia
  • hyperinsulinemia and lipidaemia
  • cardiovascular disease There is evidence linking postprandial glycaemia or glycaemic variability to the development of these conditions or in the impairment in cognitive and exercise performance.
  • marine peptide in combination with marine nucleotides may lower inflammation and stimulate gastrointestinal function.
  • L. A. Vik ⁇ ren et al. describes a study on overweight adults, wherein the effects of fish protein supplement on glucose and lipid metabolism were examined ( L. A. Vik ⁇ ren et al., "A randomised study on the effects of fish protein supplement on glucose tolerance, lipids and body composition in overweight adults", British Journal of Nutrition, 2013, vol. 109, p. 648-657 ).
  • US 2011/039768 A1 describes a fish protein hydrolysate containing molecules capable of exerting a satietogenic activity and of regulating food intake in humans and animals.
  • NO 320667 B1 discloses the use of fish protein hydrolysate for decreasing blood glucose level, and improving the general health.
  • WO 03/026682 A1 describes a composition based on fresh or conserved fish soft roe useful in manufacturing a preparation enhancing the serum immunoglobulin level, especially the IgG level, and thereby strengthens the immune system, stimulates growth and improves an individual's general state of health.
  • I. Abete et al. refers to the treatment of metabolic syndrome and thereby reviews some therapies known in the art.
  • I. Abete et al. states that the consumption of some specific foods (legumes, fatty fish, vegetables and fruits, etc) with bioactive components within an energy-restricted diet is a promising approach to manage metabolic syndrome manifestations ( I. Abete et al., "Obesity and metabolic syndrome: potential benefit from specific nutritional components", Nutrition, Metabolism and Cardiovascular Diseases, 2011, vol 21, p. B1-B15 ).
  • the present invention provides a combination of a marine peptide and a fish nucleotide for use in the treatment of a condition selected from the group consisting of pre-diabetes and diabetes, by reducing postprandial concentrations of glucose in a subject's blood. Moreover, the combination is administered to the subject prior to or during a meal and the marine peptide is a fish protein hydrolysate. Further provided is the use of a combination of a marine peptide, which is a fish protein hydrolysate, and a fish nucleotide to reduce the postprandial concentration of glucose in a subject's blood comprising administering to the subject prior to or during a meal an effective amount of the combination.
  • compositions comprising a combination of isolated marine peptide and isolated fish nucleotides in a ratio of 10:1 by weight of the total weight of the combination. Moreover, the combination is provided in an amount effective to reduce blood levels of glucose in a subject and wherein the marine peptide is a fish protein hydrolysate.
  • the invention provides a marine peptide in an amount of 20 mg to 25 mg per Kg of the body weight of the subject for use in the treatment of obesity. Furthermore, the marine peptide is administered with less than 10 % of a marine nucleotide, and moreover, the marine peptide is a fish protein hydrolysate.
  • the treatment of obesity may be by increasing postprandial concentration of GLP-1 levels in a subject's blood, or by reducing postprandial concentrations of ghrelin levels in a subject's blood, or by providing a feeling of satiety to a subject.
  • the marine peptide for use in the treatment of obesity by increasing the Glucagon Like Protein - 1 (GLP-1) level in a subject's blood may comprise administering to the subject in need of having its GLP-1 levels reduced an effective amount of a marine peptide wherein the marine peptide is administered in the substantial absence of a marine nucleotide.
  • the marine peptide is administered to the subject prior to or during a meal.
  • a marine peptide for use in the treatment of obesity by reducing postprandial concentrations of ghrelin levels in a subject's blood may comprise administering to the subject in need of having its ghrelin levels an effective amount of a marine peptide wherein the marine peptide is administered in the substantial absence of a marine nucleotide.
  • the marine peptide is administered to the subject prior to or during a meal.
  • a marine peptide for use in the treatment of obesity by providing a feeling of satiety to a subject may comprise administering to the subject in need thereof 20 to 25 mg per Kg of body weight of a subject a marine peptide wherein the marine peptide is provided in the substantial absence of a marine nucleotide.
  • a combination of a marine peptide and a fish nucleotide for use in the treatment of a condition selected from the group consisting of pre-diabetes and diabetes, by reducing postprandial concentrations of glucose in a subject's blood comprising administering to the subject an effective amount of a combination of a marine peptide and a fish nucleotide sufficient to reduce the glucose concentration in the subject's blood wherein the combination is administered to the subject prior to or during a meal.
  • the marine peptide is a fish protein hydrolysate.
  • the subject is an animal, more particularly a mammal.
  • the subject is a human.
  • the subject is in need of glucose reduction.
  • the GLP-1 levels in a subject's blood are raised, particularly where the subject is in need of such increase.
  • a combination of a marine peptide and a fish nucleotide for use in the treatment of a condition selected from the group consisting of pre-diabetes and diabetes comprising administering an effective amount of a combination of a marine peptide and a fish nucleotide to a subject having an HbA1C (glycated hemoglobin) level equal to or greater than 6 for a period of time sufficient to reduce the HbA1C level, particularly where the HbA1C level is greater than 6.5, more particularly wherein the HbA1C level is greater than 7.
  • HbA1C glycogen
  • a combination of a marine peptide and a fish nucleotide for use in the treatment of a condition selected from the group consisting of pre-diabetes and diabetes comprising administering an effective amount of a combination of a marine peptide and a fish nucleotide to a subject for a period of time sufficient to reduce the subject's insulin resistance, particularly where the subject is in need of such reduction.
  • a marine peptide and a fish nucleotide for use in the treatment of a condition selected from the group consisting of pre-diabetes and diabetes for managing the glucose levels in a subject.
  • a pharmaceutical preparation comprising a combination of a marine peptide and a fish nucleotide in an amount sufficient for the treatment, to a subject in need of such treatment, of a condition selected from the group consisting of pre-diabetes, diabetes or obesity.
  • a dietary supplement comprising a combination of a marine peptide and a fish nucleotide in an amount sufficient for the maintenance, in a subject, of blood sugar levels and/or weight health.
  • a food more particularly a functional food, comprising a combination of a marine peptide and a fish nucleotide in an amount sufficient for the maintenance, in a subject, of blood sugar levels.
  • a food more particularly a functional food, comprising a combination of a marine peptide and a fish nucleotide in an amount sufficient for the maintenance, in a subject, of glucose blood levels.
  • a combination of a marine peptide and a fish nucleotide for use in the treatment of a condition selected from the group consisting of pre-diabetes and diabetes comprising administering a food, more particularly a functional food, comprising a combination of a marine peptide and a fish nucleotide in an amount effective to manage of glucose levels in a subject.
  • a marine peptide for use in the treatment of obesity by increasing the Glucagon Like Protein - 1 (GLP-1) level in a subject's blood which may comprise administering to the subject in need of having its GLP-1 levels reduced an effective amount of a marine peptide wherein the marine peptide is administered in the substantial absence of a marine nucleotide.
  • the marine peptide is administered to the subject prior to or during a meal.
  • a marine peptide for use in the treatment of obesity by reducing postprandial concentrations of ghrelin levels in a subject's blood comprising administering to the subject in need of having its ghrelin levels an effective amount of a marine peptide wherein the marine peptide is administered in the substantial absence of a marine nucleotide.
  • the marine peptide is administered to the subject prior to or during a meal.
  • a marine peptide for use in the treatment of obesity by increasing postprandial concentrations of GLP-1 levels in a subject's blood comprising administering to the subject in need thereof a 20 mg to 25 mg per Kg of the body weight of the subject.
  • the marine peptide is administered to the subject prior to or during a meal.
  • a marine peptide in an amount of 20 mg to 25 mg per Kg of the body weight of the subject for use in the treatment of obesity by reducing postprandial concentrations of ghrelin levels in a subject's blood comprising administering to the subject in need of having its ghrelin levels reduced.
  • the marine peptide is administered to the subject prior to or during a meal.
  • the marine peptide is a fish protein hydrolysate.
  • a marine peptide in an amount of 20 mg to 25 mg per Kg of the body weight of the subject for use in the treatment of obesity by providing a feeling of satiety to a subject comprising administering to the subject in need thereof,.
  • the marine peptide is administered for a time sufficient to provide a feeling of satiety to the subject.
  • the marine peptide for use in the treatment of obesity by providing a feeling of satiety in a subject is provided in the substantial absence of a marine nucleotide, particularly less than 10%, more particularly less than 5%, more particularly less than 1%, more particularly less than 0.1%, even more particularly no marine nucleotide.
  • a dietary supplement comprising a marine peptide in an amount sufficient for the maintenance, in a subject, of GLP-1 levels wherein the supplement is provided in the substantial absence of a marine nucleotide. In one embodiment, a dietary supplement is provided comprising a marine peptide in amount sufficient for the maintenance, in a subject, of ghrelin levels wherein the supplement is provided in the substantial absence of a marine nucleotide.
  • a food more particularly a functional food, is provided comprising a marine peptide in an amount sufficient for the maintenance, in a subject, of GLP-1 levels wherein the food, more particularly a functional food, is provided in the substantial absence of a marine nucleotide.
  • a food, more particularly a functional food is provided comprising a marine peptide in an amount sufficient for the maintenance, in a subject, of ghrelin blood levels.
  • the maintenance of GLP-1 levels and/or ghrelin levels includes the management of hunger, satiety, body weight and/or obesity in a subject. Further disclosed is that the management of GLP-1 levels and/or ghrelin levels provides for the maintenance of a healthy body.
  • a pharmaceutical preparation comprising a marine peptide in an amount sufficient for the treatment of obesity.
  • the marine peptide is provided, when used in combination with a marine nucleotide, in an amount of from 5 mg to 50 mg per 1 Kg bodyweight of a subject, particularly 5 mg to 40 mg per Kg bodyweight, more particularly 10 mg to 30 mg per Kg bodyweight and even more particularly 20 mg per Kg bodyweight of the subject.
  • the marine peptide, when used in combination with a marine nucleotide is provided in an amount of 10 mg per Kg bodyweight of the subject.
  • the marine peptide, when provided in combination with a marine nucleotide is provided in an amount of 25 mg per Kg bodyweight of the subject.
  • the marine nucleotide is provided in an amount of from 0.8 to 8 mg per Kg bodyweight of a subject, particularly 0.8 mg to 6 mg per Kg body weight, more particularly 2 to 6 per Kg bodyweight and even more particularly 4 mg per Kg bodyweight of the subject. In a more particularly embodiment the marine nucleotide is provided in an amount of 2 mg per Kg bodyweight of the subject. In a further embodiment, the marine nucleotide is provided in an amount of 3 mg per Kg bodyweight of the subject.
  • a method comprising administering a marine peptide in a unit dose in, at least, an amount selected from the group consisting of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, 200 mg, 225 mg, 250 mg, 275 mg, 300 mg, 325 mg, 350 mg, 400 mg, 425 mg, 450 mg, 475 mg, 500 mg, 1000 mg, 1500 mg 2000 mg, 2500 mg and 3000 mg.
  • the unit dose comprises a fish nucleotide in an amount of 10% of the weight of the marine peptide, particularly 15% of the weight of the marine peptide, more particularly 20% of the weight of the marine peptide and even more particularly about 25% of the weight of the marine peptide.
  • the marine peptide is part of a food, more particularly a functional food, formulation where the quantity of marine peptides per serving is 200mg-2500mg.
  • marine peptide and marine nucleotide, particularly the Sodium DNA can be present in ratio of 1:4 to 1:10 per serving of food, more particularly a functional food,.
  • the level of marine nucleotides can vary from 20 to 250mg.
  • a method is provided comprising administering a marine nucleotide in a unit dose in, at least, an amount selected from the group consisting of 3 mg, 5 mg, 7.5 mg, 10 mg, 13 mg, 15 mg, 18 mg, 20 mg, 23 mg, 25 mg, 28 mg, 30 mg, 33 mg, 35 mg, 40 mg, 44 mg, 45 mg, 48 mg, 50 mg, 100 mg, 150 mg 200 mg, 250 mg and 300 mg.
  • the unit dose comprises a fish nucleotide in an amount of 10% of the weight of the marine peptide, particularly 15% of the weight of the marine peptide, more particularly 20% of the weight of the marine peptide and even more particularly 25% of the weight of the marine peptide.
  • composition comprising a combination of isolated marine peptide and isolated fish nucleotides in a ratio of 10:1 to 2:1, particularly from 6.4:1 to 4:1, more particularly at 4:1 (the ratio of the marine peptides to fish nucleotides) by weight of the total weight of the combination.
  • Also provided herein is use of a marine peptide and a fish nucleotide to reduce postprandial concentrations of glucose in a subject's blood comprising administering to the subject an effective amount of a combination of a marine peptide and a fish nucleotide sufficient to reduce the glucose concentration in the subject's blood.
  • marine peptides which may be obtained for example, but not limited to, marine algae, crustaceans and shellfish.
  • the marine peptide of the invention is obtained from fish.
  • the marine peptide of the invention is a fish protein hydrolysate.
  • the marine peptide is a fish peptide.
  • Isolated herein means for, marine peptide, marine protein hydrolysates generally processed from the marine source more particularly from fish.
  • Isolated herein means, for fish nucleotides, fish DNA or fragments thereof and physiologically acceptable salts thereof, particularly a sodium salt.
  • isolated fish nucleotides comprise DNA extracted from fish soft roe. See for example Norwegian Patent Number 20014670 .
  • the fish nucleotides comprise essentially pure DNA or fragments thereof, particularly fish nucleotides having less than 2% protein. Isolated is not meant to limit the ability in practicing embodiments herein to combine the isolated ingredients for example with fish or fish products in the preparation of a pharmaceutical product, a dietary supplement or a food, more particularly a functional food.
  • a process for making marine peptides comprising:
  • the isolated marine peptide here means marine peptides wherein at least 70%, particularly, at least 75% and more particularly at least 85% of the peptides have a molecular weight of less than 5000 Dalton (Da). In another embodiment, 90% of the peptides have a molecular weight of less than 10000 (2) Da. In one embodiment the marine peptide comprises a water free protein content of 95%. In a particular embodiment the marine peptide has the peptide molecular weight profile as set forth in (Profile I): Peptide (Molecular Weight (Da) Amount (Dried Weight Bases) >20KDa 0-5%.
  • Profile I Peptide (Molecular Weight (Da) Amount (Dried Weight Bases) >20KDa 0-5%.
  • the Molecular Weight Range of the peptides (KDa) - are, each independently, on a dried weight basis as follows (Profile 2): Peptide (Molecular Weight) Amount (Dried Weight Basis) >20KDa at ⁇ 0.1% 15KDa-20KDa at ⁇ 0.1 10KDa-15KDa at ⁇ 0.1 8KDa -10KDa at 0.1 6KDa -8KDa at 0.5% 4KDa -6KDa at 1.9 2KDa -4KDa at 6.3 1KDa -2KDa at 13.0 0.5KDa-1KDa at 18.5 0.2KDa-0.5KDa at 23.8 ⁇ 0.2KDa at 24.0 Free AA 0-20%, particularly at 3.5 EAA/NEAA ratio 0.4-0.9, particularly at 0.7
  • the sum of the branched chain amino acid is greater than or equal to 15.31 % on a total amino acids basis.
  • the indispensable amino acids or essential amino acids are 36.70% of the total amino acids.
  • the marine peptide is as described in Norwegian Patent Number 20040450 .
  • the process for making marine peptides typically begins with fresh or fresh frozen fish muscle tissue which is minced and mixed with water at a ratio 1:1 in an incubator (e.g., but not limited to a 1-20 m 3 volume incubator). The temperature is raised to 50-55 °C while the mixture stirred preferably at 50-80 rpm. An enzyme cocktail consisting of a mixture of proteases and peptidases is added (e.g., Protamex® from NOVOZYMES, Denmark) to the mixture and the temperature is brought to 50 to 55°C and the homogenate formed is incubated for 45 min at 50-55 °C at pH 6-8, preferably at 6-7.
  • an enzyme cocktail consisting of a mixture of proteases and peptidases is added (e.g., Protamex® from NOVOZYMES, Denmark) to the mixture and the temperature is brought to 50 to 55°C and the homogenate formed is incubated for 45 min at 50-55 °C at pH 6-8, preferably at 6-7.
  • the temperature is raised to 85-90 °C and kept at that temperature for 10-15 min to inactivate the enzymes.
  • the incubate is passed through a sieve to remove bones and debris, then the soluble fraction is separated from the indigestible/insoluble material using centrifugation after which the peptide rich soluble fraction is dehydrated into a concentrate, which is used for spray-drying into a powder.
  • the amino acid profile of the marine peptides made as set out above is provided in Table I.
  • Table 1 Amino acid profile in terms of dry matter Amino acids Total amino acid (mg/g) Free amino acids (mg/g) Percent (%) of total amino acids Indispensible IDAA Histidine 13,5 0,26 1,93 Threonine 30,9 1,20 3,88 Methionine 22,1 2,30 10,41 Phenylalanine 23,2 2,75 11,85 Valine 36,9 1,94 5,26 Isoleucine 30,1 1,91 6,35 Leucine 60,3 6,35 10,53 Lysin 71,3 1,36 1,91 Tryptofan 6,0 0,48 8,00 Total IDAA 367,0 18,55 5,05 Sum BCAA 153,1 10,21 6,66 Dispensible DAA Aspartic acid 73,32 1,18 1,49 Asparagine - 0,38 - Glutamic acid 125,0 5,30 4,24 Glutamine - 0,78 - Hydroxyproline 1,0 0,08 8,00 Serine 36,0 1,11 3,08 G
  • the microbiological profile of the marine peptides made as described above is provided in Table 3.
  • Table 3 Microbiology Microbiology (per gram powder) Total count (30 dgr C) 100 Enterobacteriace (37 dgr C) 0 E. coli (44,5 dgr C) 0 Staphylococcus, coagulase pos 0 ASR-Clostridium (37 dgr C) 50 ASR-Clostridium (37 dgr C) - 2 days 50 Salmonella spp Neg/25 g Listeria monocytogenes 0 Mould ⁇ 10 Yeast ⁇ 10
  • the molecular weight distribution of the marine peptid hydrolysate of the marin peptides made as set forth above is provided in Table 4.
  • Table 4 Molecular weight distribution of marine protein hydrolysate Molecular weight Distribution Amino acid moieties g/100 g soluble peptides g/100 g dry matter Chromatography > 20.000 Da ⁇ 0,1 0 20.000-15.000 Da ⁇ 0,1 0 15.000-10.000 Da ⁇ 0,1 0 10.000-8.000 Da 88-71 0,1 0,09 8.000-6.000 Da 70-53 0,6 0,54 6.000-4.000 Da 52-36 2,1 1,89 4.000-2.000 Da 35-18 7,2 6,48 2.000-1.000 Da 17-10 14,8 13,32 1.000-500 Da 9-5 21,0 18,90 500-200 Da 4-2 27,0 24,30 ⁇ 200 Da ⁇ 2 27,2 24,48 Calculated values Free amino acids 5,1 4,59 Dipeptides 19.89 Molecular weight Distribution Amino acid moieties g/100 g soluble peptides g/100 g dry matter
  • a unit dose having an effective amount of a marine peptide and a fish nucleotide.
  • the marine peptide and/or fish nucleotide is administered in a single dosage form, i.e., a dosage form, or in two or more dosage forms.
  • dosage form refers to the physical form for the route of administration.
  • drug form can refer to any traditionally used or medically accepted administrative forms, such as oral administrative forms, intravenous administrative forms, or intraperitoneal administrative forms.
  • the marine peptide and/or fish nucleotide is administered in a single dose, i.e., a unit dose.
  • a "unit dose” refers to an amount of marine peptide and/or fish nucleotide administered to a subject in a single dose, e.g., in a gel capsule.
  • the term “unit dose” can also refer to a single dosage form of a single unit of a suitable solid, liquid, syrup, beverage, or food, more particularly a functional food, item, for example, but not limited to, those used to deliver pharmaceutical, dietary supplements and food, more particularly a functional food, wherein the total dose of marine peptide and/or fish nucleotide is administered within a short period of time, e.g., within 1 minute, 2 minutes, 3 minutes, 5 minutes, 10 minutes, 20 minutes, or 30 minutes of a first portion of a dose.
  • the dose form is a food, more particularly a functional food, it may be part of any food product with 200-2000mg per serving of food, more particularly a functional food, where the serving is defined by the manufacturer/regulator based on the type of food, more particularly a functional food; for example it may be sprinkled onto the food and eaten with the meal with the above mentioned level per serving.
  • the unit dose is delivered via a unit dosage form such as tablets, capsules, cachets, pellets, pills, gelatin capsules, powders, and granules.
  • a capsule and or table that comprises 500 mg of a marine peptide and 50 mg of a marine nucleotide.
  • 1500 mg, more particularly 2000 mg of a marine peptide is provided in a single dosage unit of a beverage.
  • 150, more particularly 200 mg of a marine nucleotide is provided in a single dosage unit of a beverage.
  • the subject to be treated can be administered at least one unit dose per day.
  • the dosage forms can be taken in a single application or multiple applications per day. For example, if four capsules are taken daily, each capsule comprising 500 mg marine peptide and/or fish nucleotide, then all four capsules could be taken once daily, or 2 capsules could be taken twice daily, or 1 capsule could be taken every 6 hours. Various amounts of marine peptide and/or fish nucleotide can be in a unit dose.
  • the unit dose comprises 25 mg, 50 mg, 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, 200 mg, 225 mg, 250 mg, 275 mg, 300 mg, 325 mg, 350 mg, 400 mg, 425 mg, 450 mg, 475 mg, 500 mg, 1000 mg, 1500 mg 2000 mg, 2500 mg and 3000 mg.
  • administering refers to the application of the composition, e.g., oral or parenteral (e.g., transmucosal, intravenous, intramuscular, subcutaneous, rectal, intravaginal, or via inhalation) to the subject.
  • Administering would also include the act of prescribing a composition described herein to a subject by a medical professional.
  • Administering can also include the act of labeling a composition, i.e., instructing a subject to administer a composition, in a manner as provided herein for treatment.
  • administration may be by parenteral, subcutaneous, intravenous (bolus or infusion), intramuscular, or intraperitoneal routes. Dosage forms for these modes of administration may include conventional forms, either as liquid solutions or suspensions, solid forms suitable for solution or suspension in liquid prior to injection, or as emulsions.
  • a route of administration is oral administration.
  • the marine peptide and/or fish nucleotide is administered to individuals in the form of nutritional supplements, foods, pharmaceutical formulations, or beverages, particularly foods, beverages, or nutritional supplements, more particularly, foods and beverages, more particularly foods.
  • a particular type of food is a functional or medical food (e.g., a food which is in a formulation to be consumed or administered externally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation).
  • Dietary supplements is interchangeable with nutritional supplements and may include a food preparation.
  • the marine peptide and/or fish nucleotide can be formulated in a dosage form.
  • dosage forms can include, but are not limited to, tablets, capsules, cachets, pellets, pills, gelatin capsules, powders, and granules.
  • Parental dosage forms which include, but are not limited to, solutions, suspensions, emulsions, coated particles, and dry powder comprising an effective amount of the marine peptide and/or fish nucleotide as taught in this invention.
  • the dosage form can be inserted or mixed into a food substance.
  • the dosage form is a capsule, wherein the capsule is filled with a solution, suspension, or emulsion comprising the marine peptide and/or fish nucleotide.
  • the active ingredients can be contained in such formulations with pharmaceutically acceptable excipients such as diluents, fillers, disintegrants, binders, lubricants, surfactants, hydrophobic vehicles, water soluble vehicles, emulsifiers, buffers, humectants, moisturizers, solubilizers, preservatives, flavorants, taste-masking agents, sweeteners, and the like.
  • suitable excipients can include, e.g., vegetable oils (e.g., corn, soy, safflower, sunflower, or canola oil).
  • the preservative can be an antioxidant, e.g., sodium sulfite, potassium sulfite, metabisulfite, bisulfites, thiosulfates, thioglycerol, thiosorbitol, cysteine hydrochloride, alpha-tocopherol, and combinations thereof.
  • an antioxidant e.g., sodium sulfite, potassium sulfite, metabisulfite, bisulfites, thiosulfates, thioglycerol, thiosorbitol, cysteine hydrochloride, alpha-tocopherol, and combinations thereof.
  • Test subjects were instructed to rest in bed after ingesting the test diet; blood samples were drawn no later than 5 min before ingesting the diets, and at 20 min intervals for 120 min following ingestion the test diets. The diets were taken within a period of 5 min.
  • Diet B, C and D were given in amounts equivalent to 20 mg of peptide/kg bodyweight/dose and compared to equal intake of control Diet A in terms of energy and protein.
  • the diets were taken as fluid meals.
  • Mixing ratio 1 g powder plus 4 ml cold water.
  • the dietary distribution of protein, fat and carbohydrate is 30, 11 and 55 %, respectively; the energy content was 4.4 Kcal/gram dry matter.
  • the diets were given a natural strawberry flavor to level out any taste differences between diets.
  • the Subjects were fasting and were not allowed to eat any breakfast before this visit and come to clinic in the morning. Vital sign and a pre-ingestion blood sample were taken. After the diet was ingested blood samplings were taken at the following time points: 20 min, 40 min, 60 min, 80 min, 100 min, and 120 min.
  • the Subjects were fasting and were instructed to not eat breakfast before this visit.
  • a pre-ingestion blood sample was taken. After the diet was ingested blood was taken at the following time points: 20 min, 40 min, 60 min, 80 min, 100 min, and 120 min.
  • the Subjects were fasting and were instructed to not eat breakfast before this visit.
  • a pre-ingestion blood sample was taken. After the diet has been ingested blood is taken at the following time points: 20 min, 40 min, 60 min, 80 min, 100 min, and 120 min.
  • the Subjects were fasting and were instructed to not eat breakfast before this visit.
  • a pre-ingestion blood sample was taken. After the diet was ingested blood was taken at the following time points: 20 min, 40 min, 60 min, 80 min, 100 min, and 120 min.
  • the area under the curve is calculated by taking the average response of all 12 participants and using the sum of positive responses in terms of mmol glucose per L blood exceeding the baseline (0 on the y-axis in the figure) without including the negative values (i.e. values below the baseline representing the rebound effect of insulin) and the following results were obtained:
  • Marine Peptides lowered the postprandial blood glucose peak by 0.7 and 0.8 mmol/L, respectively, as compared to the Control and the Whey Peptide diets corresponding to 33 and 35 %, respectively.
  • the concentration of Ghrelin was measured at 4 different times following the ingestion of the diet; assuming a Ghrelin negative peak at 60 min postprandialy the analysis showed:
  • the concentration of Ghrelin is inversely related to the feeling of hunger, consequently the lower the concentration of ghrelin in blood the stronger is the feeling of satiety.
  • the data shows that marine peptides strongly affect the secretion of Ghrelin, and is assumed to also affect the feeling of satiety.
  • the result for the marine peptide alone was shown to be higher than for whey peptide.
  • the combination of marine peptide and marine nucleotide did not show a response.
  • the concentration of GLP-1 was measured at four different times following the ingestion of the test diet; assuming a GLP-1 peak at 60 min postprandialy the analysis showed:
  • GLP-1 has a variety of functions in the body, among them participating in the management of hunger and safety. Increased GLP-1 concentration of the blood lowers the feeling of hunger and prolongs the feeling of satiety.

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Claims (25)

  1. Combinaison d'un peptide marin et d'un nucléotide de poisson destinée à être utilisée dans le traitement d'une condition choisie dans le groupe constitué par un pré-diabète et un diabète, en réduisant les concentrations postprandiales en glucose dans le sang d'un sujet, la combinaison étant administrée au sujet avant ou au cours d'un repas et dans laquelle le peptide marin est un hydrolysat de protéines de poisson.
  2. Combinaison destinée à être utilisée tel que cité dans la revendication 1, dans laquelle le sujet est un être humain.
  3. Combinaison destinée à être utilisée tel que cité dans les revendications 1 ou 2, dans laquelle le sujet nécessite une telle réduction.
  4. Combinaison destinée à être utilisée tel que cité dans les revendications 1 à 3, dans laquelle le peptide marin est fourni en une quantité de 5 mg jusqu'à 50 mg par kg de poids corporel du sujet.
  5. Combinaison destinée à être utilisée tel que cité dans la revendication 4, dans laquelle le peptide marin est fourni en une quantité de 20 mg par kg de poids corporel du sujet.
  6. Combinaison destinée à être utilisée tel que cité dans les revendications 1 à 5, la combinaison étant administrée au sujet pendant une durée suffisante pour réduire la résistance du sujet à l'insuline.
  7. Combinaison destinée à être utilisée tel que cité dans les revendications 1 à 5, la combinaison étant administrée à un sujet ayant un taux de HbA1C supérieur ou égal à 6 pendant une durée pour réduire le taux de HbA1C.
  8. Combinaison destinée à être utilisée tel que cité dans la revendication 7, dans laquelle le taux de HbA1C est supérieur à 6,5.
  9. Combinaison destinée à être utilisée tel que cité dans la revendication 8, dans laquelle le taux de HbA1C est supérieur à 7.
  10. Combinaison destinée à être utilisée tel que cité selon l'une quelconque des revendications 1 à 9, la combinaison étant fournie sous forme d'aliment destiné à la gestion des taux de glucose chez le sujet.
  11. Combinaison destinée à être utilisée tel que cité dans l'une quelconque des revendications 1 à 9, la combinaison étant fournie sous forme d'un complément alimentaire destiné au maintien des taux de sucre dans le sang.
  12. Combinaison destinée à être utilisée tel que cité dans l'une quelconque des revendications 1 à 9, dans lequel le nucléotide de poisson est fourni en une quantité égale à 25% du poids du peptide marin.
  13. Peptide marin en une quantité de 20 mg jusqu'à 25 mg par kg de poids corporel du sujet destiné à être utilisé dans le traitement de l'obésité, le peptide marin étant administré avec moins de 10% d'un nucléotide marin, et le peptide marin étant un hydrolysat de protéines de poisson.
  14. Peptide marin destiné à être utilisé tel que cité dans la revendication 13, en augmentant la concentration postprandiale des taux de GLP-1 dans le sang d'un sujet, le peptide marin étant administré au sujet avant ou au cours d'un repas.
  15. Peptide marin destiné à être utilisé tel que cité dans la revendication 13, en réduisant les concentrations postprandiales des taux de ghréline dans le sang d'un sujet.
  16. Peptide marin destiné à être utilisé tel que cité dans la revendication 13, en apportant une sensation de satiété à un sujet.
  17. Peptide marin destiné à être utilisé tel que cité dans les revendications 13 à 16, dans lequel le sujet est un être humain.
  18. Peptide marin destiné à être utilisé tel que cité selon la revendication 14, le peptide marin étant fourni sous forme d'un complément alimentaire destiné au maintien des taux de GLP-1 chez le sujet.
  19. Peptide marin destiné à être utilisé tel que cité selon la revendication 14, le peptide marin étant fourni sous forme d'un aliment destiné à la gestion des taux de GLP-1 chez le sujet.
  20. Peptide marin destiné à être utilisé tel que cité selon la revendication 15, le peptide marin étant fourni sous forme d'un complément alimentaire destiné au maintien des taux de ghréline chez un sujet.
  21. Peptide marin destiné à être utilisé tel que cité selon la revendication 15, le peptide marin étant fourni sous forme d'un aliment destiné à la gestion des taux de ghréline chez un sujet.
  22. Peptide marin destiné à être utilisé tel que cité selon l'une quelconque des revendications 13 à 16, le peptide marin étant fourni sous forme d'une préparation pharmaceutique destinée au traitement de l'obésité.
  23. Peptide marin destiné à être utilisé tel que cité dans l'une quelconque des revendications 13 à 16, le peptide marin étant fourni dans un complément alimentaire destiné au maintien d'un corps en bonne santé.
  24. Peptide marin destiné à être utilisé tel que cité dans l'une quelconque des revendications 20 à 22, le peptide étant administré sous forme d'au moins une dose unitaire en une quantité choisie dans le groupe constitué par 25 mg, 50 mg, 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, 200 mg, 225 mg, 250 mg, 275 mg, 300 mg, 325 mg, 350 mg, 400 mg, 425 mg, 450 mg, 475 mg, 500 mg, 1000 mg, 1500 mg 2000 mg, 2500 mg et 3000 mg.
  25. Composition comprenant une combinaison d'un peptide marin isolé et de nucléotides de poisson isolés en un rapport de 10:1 en poids du poids total de la combinaison, la combinaison étant fournie en une quantité efficace pour réduire les taux sanguins de glucose chez un sujet, et dans laquelle le peptide marin est un hydrolysat de protéines de poisson.
EP15745185.7A 2014-07-31 2015-07-30 Peptides marins et nucleotides de poissons, compositions et leurs utilisations pour la reduction de la glycemie Active EP3174548B1 (fr)

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JPH0198445A (ja) * 1987-10-12 1989-04-17 Kanebo Ltd 経口摂食組成物
JP2764276B2 (ja) * 1988-09-06 1998-06-11 仙味エキス株式会社 機能性新規ペプチド及びその利用
JPH111495A (ja) * 1997-06-10 1999-01-06 Horiuchi Shokuhin Kogyo Kk アマノリ属海藻からのポリペプチドの製造方法
JP4862235B2 (ja) * 2001-02-27 2012-01-25 Ｊｎｃ株式会社 血糖値上昇抑制剤
JP2002338482A (ja) * 2001-05-22 2002-11-27 Hayashikane Sangyo Kk インシュリン抵抗性改善剤、及び、インシュリン抵抗性改善用食品、飲料及び錠剤
NO315184B1 (no) * 2001-09-26 2003-07-28 Firmenich & Cie Anvendelse av en sammensetning basert på fiskemelke for fremstilling av etpreparat som öker immunoglobulinproduksjonen
NO320667B1 (no) * 2004-02-02 2006-01-16 Einar Lied Andvendelse av en sammensetning basert på fiskekjøtt for fremstilling av et preparat som reduserer økningen i blodglukose etter fødeinntak
WO2006026682A2 (fr) 2004-08-30 2006-03-09 Hunter Douglas Inc. Dispositif, logiciel et procede de commande d'un ecran de fenetre
GB0717911D0 (en) * 2007-09-14 2007-10-24 Univ Stirling Vaccine
FR2927335B1 (fr) * 2008-02-12 2012-04-20 Cie Des Peches Saint Malo Sante Hydrolysat de proteines de poissons presentant une activite satietogene, compositions nutraceutiques et pharmacologiques comprenant un tel hydrolysat et procede d'obtention
JP4750213B1 (ja) * 2010-05-21 2011-08-17 株式会社 ファイナルフューチャーインターナショナル アディポネクチン産生促進組成物

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CN106573034B (zh) 2021-12-17
WO2016016350A1 (fr) 2016-02-04
JP2017523203A (ja) 2017-08-17
JP6829186B2 (ja) 2021-02-10
MX2017000878A (es) 2017-05-04
BR112017001589A2 (pt) 2018-01-30
EP3174548A1 (fr) 2017-06-07
US20170258866A1 (en) 2017-09-14
CN106573034A (zh) 2017-04-19

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